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IRCT20260212068838N1 IRCT 2026-03-22 Semnan University of Medical Sciences Comparison of the Effects of Primary Motor Cortex Magnetic Stimulation and Cerebellar Stimulation on Reducing Muscle Spasticity in Stroke Patients iTBS Investigation of Neurophysiological and Clinical Effects of Transcranial Magnetic Stimulation of the Motor Cortex Compared to Stimulation of the Cerebellum in Patients with Spastic Stroke 2026-04-04 anticipated 27 Recruiting https://irct.ir/trial/89101 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization With A Block Size Of 3 (Equal To The Number Of Study Groups) Will Be Used To Ensure Balanced Allocation Of Participants Across All Groups Throughout The Recruitment Process. For Each Three-Participant Block, Six Possible Allocation Sequences Exist: T1T2C, T1CT2, T2T1C, T2CT1, CT1T2, CT2T1 Using Microsoft Excel Software, Nine Random Blocks Will Be Generated, Providing A Total Of 27 Allocation Slots For Participant Assignment. The Allocation Sequence For Each Block Will Be Placed In Opaque Sealed Envelopes And Opened Sequentially According To The Order Of Participant Enrollment To Maintain Allocation Concealment, Blinding description: he researcher will be blind to the intervention using the research assistant and he/she is absent in the treatment room. The outcome evaluator will vary with the researcher and research data be given him with code and is unaware of the participants intervention. N/A Spastic Stroke. Intervention 1: Intervention group: The group receiving transcranial magnetic stimulation of the motor area of ​​the brain (M1-iTBS). To stimulate the M1, iTBS will apply over the motor hotspot of the affected extensor carpi radialis brevis muscle. The stimulation intensity is 80% of the resting motor threshold. The iTBS protocol consists of 10 bursts, each of which is compose of three stimuli at 50 Hz, repeated at a theta frequency of 5 Hz every 10 s for a total of 600 stimuli (200 s). Each patient received 10 session of treatment. Intervention 2: Intervention group: The group receiving transcranial magnetic stimulation of the cerebellum (Cerebellum-iTBS). In this group, iTBS will apply over the contralesional cerebellum. The stimulation intensity is 80% of the resting motor threshold. The iTBS protocol consists of 10 bursts, each of which is compose of three stimuli at 50 Hz, repeated at a theta frequency of 5 Hz every 10 s for a total of 600 stimuli (200 s). Each patient received 10 session of treatment. Intervention 3: Control group: Group receiving sham transcranial magnetic stimulation (sham-iTBS). In the sham iTBS group, iTBS was randomly applied over the M1 or cerebellum. Stimulation in the sham rTMS group is turn off, while the coils remained in place and a noise similar to the sound of real iTBS was heard in the space. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Mona Ramezani
Neuromuscular Rehabilitation Research Center, Tabatabaee Clinic, Qods Blvd., Semnan
Semnan Iran (Islamic Republic of) 3519618375 +98 23 8502 3332 mona.ramezani.sa@gmail.com Semnan University of Medical Sciences scientific Fatemeh Ehsani
Neuromuscular Rehabilitation Research Center, Tabatabaee Clinic, Qods Blvd., Semnan
Semnan Iran (Islamic Republic of) 3519618375 +98 23 8502 3332 fatemehehsani59@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Patients with Stroke Aged 40 to 75 Years At Least 6 Months And No More Than 2 Years Have Passed Since The Onset Of Stroke Unilateral Ischemic Or Hemorrhagic Stroke Confirmed By CT Scan Or MRI Presence Of Spasticity In The Wrist Flexor Muscles With A Score Greater Than 1 On The Modified Modified Ashworth Scale (MMAS) No History Of Botulinum Toxin Injection Within The Past 6 Months Adequate Cognitive Ability To Complete The Assessment Procedures And Treatment Protocol 40 years 75 years Both Patients With Cerebellar Or Brainstem Lesions Presence Of Severe Psychiatric Or Communication Disorders That Interfere With Cooperation In The Study Process Progressive Neurological Diseases Such As Neurodegenerative Disorders And Active Medical Conditions Including Infections Presence Of Concomitant Neurological Diseases Or Orthopedic Disorders Affecting Upper Limb Function Individuals With Contraindications To Intermittent Theta Burst Stimulation (iTBS) Such As History Of Seizure, Cerebral Aneurysm, Intracranial Metal Implants, Cardiac Pacemaker, Or Pregnancy Inability To Understand Or Comply With The Study Procedures G80.2 Spastic hemiplegic cerebral palsy Treatment - Devices Treatment - Devices Treatment - Devices Intervention group: The group receiving transcranial magnetic stimulation of the motor area of ​​the brain (M1-iTBS). To stimulate the M1, iTBS will apply over the motor hotspot of the affected extensor carpi radialis brevis muscle. The stimulation intensity is 80% of the resting motor threshold. The iTBS protocol consists of 10 bursts, each of which is compose of three stimuli at 50 Hz, repeated at a theta frequency of 5 Hz every 10 s for a total of 600 stimuli (200 s). Each patient received 10 session of treatment. Intervention group: The group receiving transcranial magnetic stimulation of the cerebellum (Cerebellum-iTBS). In this group, iTBS will apply over the contralesional cerebellum. The stimulation intensity is 80% of the resting motor threshold. The iTBS protocol consists of 10 bursts, each of which is compose of three stimuli at 50 Hz, repeated at a theta frequency of 5 Hz every 10 s for a total of 600 stimuli (200 s). Each patient received 10 session of treatment. Control group: Group receiving sham transcranial magnetic stimulation (sham-iTBS). In the sham iTBS group, iTBS was randomly applied over the M1 or cerebellum. Stimulation in the sham rTMS group is turn off, while the coils remained in place and a noise similar to the sound of real iTBS was heard in the space. Motor Cortex Excitability Of The Affected Hemisphere Based On Resting Motor Threshold (RMT) Of The Extensor Carpi Radialis Brevis Muscle. Timepoint: Before The Intervention, 10 Days After The Start Of The Intervention, And One Month After The End Of The Intervention. Method of measurement: Transcranial Magnetic Stimulation Device. Amplitude of Motor Evoked Potential (MEP) Responses of the Extensor Carpi Radialis Brevis Muscle in the Affected Hemisphere. Timepoint: Before The Intervention, 10 Days After The Start Of The Intervention, And One Month After The End Of The Intervention. Method of measurement: Surface Electromyography. Evoked Silent Period (ESP) of the Extensor Carpi Radialis Brevis Muscle in the Affected Hemisphere. Timepoint: Before The Intervention, 10 Days After The Start Of The Intervention, And One Month After The End Of The Intervention. Method of measurement: Transcranial Magnetic Stimulation Device. Wrist Flexor Muscle Spasticity. Timepoint: Before The Intervention, 10 Days After The Start Of The Intervention, And One Month After The End Of The Intervention. Method of measurement: Modified Modified Ashworth Scale. Wrist flexor and extensor muscle activity recorded as Root Mean Square (RMS) of the sEMG signal in active and passive movements. Timepoint: Before The Intervention, 10 Days After The Start Of The Intervention, And One Month After The End Of The Intervention. Method of measurement: Surface Electromyography. Quality of Life. Timepoint: Before The Intervention, 10 Days After The Start Of The Intervention, And One Month After The End Of The Intervention. Method of measurement: Stroke-specific Quality of Life Questionnere. Upper Limb Function. Timepoint: Before The Intervention, 10 Days After The Start Of The Intervention, And One Month After The End Of The Intervention. Method of measurement: Fugl-Meyer Assessment. Semnan University of Medical Sciences Approved 2026-01-19 کمیته اخلاق دانشگاه علوم پزشکی سمنان Headquarters of Semnan University of Medical Sciences, Basij Blvd., Semnan Semnan Semnan Iran (Islamic Republic of)